Details for New Drug Application (NDA): 021180

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NDA 021180 describes ORTHO EVRA, which is a drug marketed by Janssen Pharms and is included in one NDA. Additional details are available on the ORTHO EVRA profile page.

The generic ingredient in ORTHO EVRA is ethinyl estradiol; norelgestromin. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.

Summary for 021180

Tradename:	ORTHO EVRA
Applicant:	Janssen Pharms
Ingredient:	ethinyl estradiol; norelgestromin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	0.035MG/24HR;0.15MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Nov 20, 2001	TE:		RLD:	Yes

Expired US Patents for NDA 021180

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	ORTHO EVRA	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	021180-001	Nov 20, 2001	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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